Welcome back to the Ennovation Podcast, where we bring you the latest trends, insights, and expertise in life sciences and regulatory affairs. This time, I’m joined by Pierre Stanislawski, our IDMP expert, and Josh Keliher, who’s leading the charge on AI at Ennov. Together, we dive into two major questions: what does AI really mean for regulatory affairs? And is IDMP finally ready for launch?

Our Top Resources:

> What to look for in an AI vendor. Download the AI Vendor Checklist [https://en.ennov.com/insider/guide-ai-vendor-checklist/]

> See what AI can actually do. Explore use cases in Life Sciences [https://en.ennov.com/platform/artificial-intelligence/#use-cases]

> Simplify agency correspondence. Watch the webinar to see AI in action [https://en.ennov.com/insider/managing-agency-correspondence-with-ai/]

> Know what’s coming next. View our updated EMA Timeline [https://en.ennov.com/blog/regulatory-blog/portfolio-ready-data-enrichment/]

> Current RIM not IDMP-ready? See how Ennov EASI can help [https://en.ennov.com/solutions/regulatory/idmp-easi/]

> Preparing for IDMP enrichment? Download the IDMP Starter Pack [https://en.ennov.com/insider/regulatory/idmp-starter-pack/]

AI Reality Check & The IDMP Countdown

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs. For the first episode, I’m joined by Diarmuid Waide, regulatory expert, and Sean Carpenter, Product Manager.  We discuss the latest eCTD 4.0 news and a recent MHRA consultation on Medical Devices.

 * Know what’s coming, when. Check out our eCTD 4.0 implementation timeline [https://en.ennov.com/blog/regulatory-blog/ectd-4-0-timeline/]
 * Be part of the future of publishing. Download Diarmuid’s pilot readiness checklist [https://en.ennov.com/insider/regulatory/ectd-4-0-pilot-readiness-checklist/]
 * Get prepared. Catch up on the MHRA’s proposals [https://en.ennov.com/blog/mhra-medical-devices-in-vitro-diagnostics/]
 * Is your RIM system built for Medical Devices? Navigate MDR/IVDR and UDI with ease with Ennov RIM [https://en.ennov.com/insider/regulatory/compliance-without-compromise-med-device/]

eCTD 4.0 & Medical Devices: What's Happening in 2025?

Welcome to the Ennovation Podcast, where we bring you the latest trends, insights and expertise in life sciences and regulatory affairs.

Ennov

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